In the diagnosis and treatment of breast cancer, it is often necessary to locate, sample and remove a suspicious mass. The suspicious mass is typically discovered during a preliminary examination involving visual examination, palpitation, X-ray, MRI, ultrasound or other imaging or detection means. When this preliminary examination reveals a suspicious mass, the mass must be evaluated in order to determine whether the mass is malignant or benign. Typically, the mass is biopsied and processed by a pathology laboratory to determine whether the mass is malignant or benign. Such methods are used for early diagnosis of breast cancer, as well as other forms of cancer. The early diagnosis and subsequent treatment can prevent the spread of cancerous cells to other parts of the body and ultimately prevent fatal results.
In a breast biopsy, for example, biopsy methods may be performed by either an open procedure or a percutaneous method. The open surgical biopsy procedure first requires localization of the lesion by insertion of a wire localization while using a visualization technique, such as X-ray or ultrasound. Next, the patient is taken to a surgical room where a large incision is made in the breast, and the tissue surrounding the wire loop is removed. This procedure causes significant trauma to the breast tissue, often leaving disfiguring results and requiring considerable recovery time for the patient. This is often a deterrent to patients receiving the medical care they require. The open technique, as compared to the percutaneous method, presents increased risk of infection and bleeding at the sample site.
Percutaneous biopsies have been performed using either fine needle aspiration or core biopsy in conjunction with real-time visualization techniques, such as ultrasound, mammography (X-ray), MRI, PET, CT, terahertz technologies, etc. Fine needle aspiration involves the removal of a small number of cells using an aspiration needle. A smear of the cells is then analyzed using cytology techniques. Although fine needle aspiration is less intrusive than an open procedure, only a small amount of cells are available for analysis. In addition, this method does not provide for a pathological assessment of the tissue, which can provide a more complete assessment of the stage of the cancer, if found. In contrast, in core biopsy a larger fragment of tissue can be removed without destroying the structure of the tissue. Consequently, core biopsy samples can be analyzed using a more comprehensive histology technique, which indicates the stage of the cancer. In the case of small lesions, the entire mass may be removed using the core biopsy method. For these reasons core biopsy is often preferred, and there has been a trend towards the core biopsy method so that a more detailed picture can be constructed by pathology of the disease's progress and type.
However, each of the methods described above require that process steps be followed for the preparation of the sampled tissue by a lab (cytology or pathology) leading to significant time between the taking of a tissue sample and actually determining the tissue health due to the cytological or histological techniques employed. In the case of patient care in breast disease diagnosis and subsequent treatment, the patient has left the diagnostic location and the diagnostic room is prepared for another patient. After the initial determination is made, for example where the tissue is found to be malignant, the patient is contacted and another appointment is made for a return the diagnostic location. After the patient returns, the mass must again be located before removal in a surgical environment. Thus, even after a first sample is taken to obtain a diagnosis, a second procedure must be performed to localize the mass before the patient can be scheduled for the removal of the mass in a surgical suite. Additionally, the step of localization of the mass in this process of patient care is inaccurate. Localization devices do not always get placed in the exact location intended, or they move or shift after placement or they are not so clearly found or identified while in the surgical procedure to remove the intended mass. Even once the patient is in the surgical procedure the need for the pathology lab is still required. Often the pathology department in the hospital is called upon to “read the excised tissue” during the procedure to determine if adequate tissues have been removed to confirm in the surgeons desire to achieve clear margins during the excision of the mass. This often leads to delays during the surgical procedure since the lab must find time in their busy schedule to process the tissue and then evaluate the status of the tissue all while the patient is lying in the operating room.
In light of the foregoing disadvantages, a need remains for a diagnostic system that improves the response time for diagnosis and treatment of suspicious tissue. Moreover, where desired, the diagnostic and treatment system may also provide for removal of the tissue at a particular location where a sample is taken. It is further desired that the system be able to detect suspicious tissue in less time than standard techniques. Moreover, it is preferred that the system detect suspicious tissue in real-time or near-real-time. A need also remains for a diagnostic system that is compatible with multiple imaging modalities including, but not limited to MRI.